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Osteo Arthritis KneeNCT03656445

Tranexamic Acid in Total Knee Replacement

A study testing Tranexamic Acid in people with Osteo Arthritis Knee, run by Democritus University of Thrace.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
1 Oct 2015to 31 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • varus deformity less than 10o
  • lack of extension not more than 10o
  • flexion of at least 90o.

Who cannot join

  • uncontrolled medical diseases/comorbidities
  • allergy and/or hypersensitivity to TXA
  • a known history of thromboembolic disease, cardiovascular disease
  • coronary or vascular stent placed within the past 12 months
  • cerebral vascular disease (a history of stroke)
  • subarachnoid hemorrhage
Show all 10Show fewer
  • preoperative coagulopathy (a platelet [PLT] count <150,000/mm3 or an international normalized ratio greater than 1.5
  • preoperative renal or hepatic dysfunction
  • retinal vein or artery occlusion
  • patients with anemia (<12 g/dL for female, <13 g/dL for male)

About this study

Official title: Multiple Intravenous Tranexamic Acid Doses Can Reduce Postoperative Blood Loss and Improve the Functional Outcome in Total Knee Arthroplasty Without Tourniquet: a Randomized Controlled Study

Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

Read the detailed description

A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Being tested
Tranexamic Acid
Keywords
total knee arthroplasty, tranexamic acid, without tourniquet, blood loss, function, multiple doses
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called Transamin, Cyklokapron

    1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia

  • Tranexamic AcidDrug

    Also called Transamin, Cyklokapron

    1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision

  • Tranexamic AcidDrug

    Also called Transamin, Cyklokapron

    1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel

Study groups in NCT03656445
Study groupRoleWhat they receive
Group A - Tranexamic AcidActive comparator1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
Receives: Drug: Tranexamic Acid
Group B - Tranexamic AcidActive comparator1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision
Receives: Drug: Tranexamic Acid
Group C - Tranexamic AcidActive comparator1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectively
Receives: Drug: Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hemoglobin change

    Hemoglobin decrease/change during the four post-operative days

    Measured: 1st,2nd and 4th post-operative day

  2. Blood loss

    calculated total blood loss (TBL) the 1st post-op day

    Measured: 24 hours

  3. Blood loss

    calculated total blood loss (TBL) the 2nd post-op day

    Measured: 48 hours

  4. Blood loss

    calculated total blood loss (TBL) the 4th post-op day

    Measured: 96 hours

  5. Platelet count change

    Platelet count increase/decrease/change during the 1st,2nd and 4th day

    Measured: 24 hours, 48 hours, 96 hours

  6. Need for trasfussion

    Transfussion rate/quantity in 1st post-op day

    Measured: 24 hours

  7. Need for trasfussion

    Transfussion rate/quantity in 2nd post-op day

    Measured: 48 hours

  8. Need for trasfussion

    Transfussion rate/quantity in 3rd post-op day

    Measured: 96 hours

Secondary outcomes (4)

  1. Knee Society Score (KSS) KSS

    Change in this Score which is an objective scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)

    Measured: 2nd and 4th post op days + 6th week and 12th week

  2. Function Knee Society Score

    Change in this score which utilizes walking distance and stair climbing as the main parameters, with deduction for the use of a walking aid. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)

    Measured: 2nd and 4th post op days + 6th week and 12th week

  3. EuroQol

    Changes in this score which is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Crosswalk value sets for the EQ-5D-5L has been used to asses the results into numbers. Maximum score is 1 (which means best quality of life) and the lowest is -0.594(which means the worst quality of life)

    Measured: 2nd and 4th post op days + 6th week and 12th week

  4. VAS pain (analogue pain scale)

    The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 [100-mm scale])

    Measured: 2nd and 4th post op days + 6th week and 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start1 Oct 2015
  3. Primary completion31 Mar 2017
  4. Study completion31 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656445
Sponsor's protocol ID
546a - 26/10/2015
Status last verified
Aug 2018
First submitted
30 Aug 2018
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clinics in geriatric medicine. Aug 2010;26(3):355-369. 2. Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. British medical bulletin. 2013;105:185-199. 3. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. The Journal of bone and joint surgery. American volume. Apr 2007;89(4):780-785. 4. Bourne RB, McCalden RW, MacDonald SJ, Mokete L, Guerin J. Influence of patient factors on TKA outcomes at 5 to 11 years followup. Clinical orthopaedics and related research. Nov 2007;464:27-31. 5. Anderson JG, Wixson RL, Tsai D, Stulberg SD, Chang RW. Functional outcome and patient satisfaction in total knee patients over the age of 75. The Journal of arthroplasty. Oct 1996;11(7):831-840. 6. Mulhall KJ, Ghomrawi HM, Bershadsky B, Saleh KJ. Functional improvement after total knee arthroplasty revision: new observations on the dimensional nature of outcome. Journal of orthopaedic surgery and research. Dec 07 2007;2:25. 7. Saleh KJ, Dykes DC, Tweedie RL, et al. Functional outcome after total knee arthroplasty revision: a meta-analysis. The Journal of arthroplasty. Dec 2002;17(8):967-977. 8. Sikorski JM. Alignment in total knee replacement. The Journal of bone and joint surgery. British volume. Sep 2008;90(9):1121-1127. 9. Blumberg N. Allogeneic transfusion and infection: economic and clinical implications. Semin Hematol. 1997/07// 1997;34(3 Suppl 2):34-40. 10. Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. Apr 09 2009;113(15):3406-3417. 11. Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. The Journal of arthroplasty. Sep 2010;25(6 Suppl):2-4. 12. Themistoklis T, Theodosia V, Konstantinos K, Georgios DI. Perioperative blood management strategies for patients undergoing total knee replacement: Where do we stand now? World journal of orthopedics. Jun 18 2017;8(6):441-454. 13. Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. Journal of orthopaedic surgery and research. 2014;9:13-13. 14. Zhang Q, Dong J, Gong K, Li X, Zheng S, Wen T. [Effects of Tourniquet Use on Perioperative Outcome in Total Knee Arthroplasty]. Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. Apr 2016;30(4):421-425. 15. Du Z, Liu P, Zhang Y, Li D, Li M. [Effect of tourniquet on perioperative blood loss and short-term effectiveness in total knee arthroplasty]. Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. Nov 2013;27(11):1318-1323. 16. Li X, Yin L, Chen ZY, et al. The effect of tourniquet use in total knee arthroplasty: grading the evidence through an updated meta-analysis of randomized, controlled trials. European journal of orthopaedic surgery & traumatology : orthopedie traumatologie. Aug 2014;24(6):973-986. 17. Tetro AM, Rudan JF. The effects of a pneumatic tourniquet on blood loss in total knee arthroplasty. Canadian journal of surgery. Journal canadien de chirurgie. Feb 2001;44(1):33-38.

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic Acid in people with Osteo Arthritis Knee, run by Democritus University of Thrace.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hemoglobin change (time frame: 1st,2nd and 4th post-operative day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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